Evidence map›Paper›PMID 32134686›Full record

ArticleJCO clinical cancer informatics2020

Developing an FHIR-Based Computational Pipeline for Automatic Population of Case Report Forms for Colorectal Cancer Clinical Trials Using Electronic Health Records.

Nansu Zong, Andrew Wen, Daniel J Stone, Deepak K Sharma, Chen Wang, Yue Yu, Hongfang Liu, Qian Shi, Guoqian Jiang

Abstract read
In one paragraph

Article in JCO clinical cancer informatics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed.

  1. Article
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  7. Review
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  9. Review
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  11. Web-based Prototype for Graphical Exploration of FHIR® Questionnaire Responses.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2023
    Article
  12. Article
  13. HL7 FHIR-based tools and initiatives to support clinical research: a scoping review.Journal of the American Medical Informatics Association : JAMIA · 2022
    Article
  14. Review
  15. Article
  16. Electronic health records and patient registries in medical oncology departments in Spain.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
    Article
  17. Key Contributions in Clinical Research Informatics.Yearbook of medical informatics · 2021
    Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Nansu ZongDepartment of Health Sciences Research, Mayo Clinic, Rochester, MN.
Andrew WenDepartment of Health Sciences Research, Mayo Clinic, Rochester, MN.
Daniel J StoneDepartment of Health Sciences Research, Mayo Clinic, Rochester, MN.
Deepak K SharmaDepartment of Health Sciences Research, Mayo Clinic, Rochester, MN.
Chen WangDepartment of Health Sciences Research, Mayo Clinic, Rochester, MN.
Yue YuDepartment of Health Sciences Research, Mayo Clinic, Rochester, MN.
Hongfang LiuDepartment of Health Sciences Research, Mayo Clinic, Rochester, MN.
Qian ShiDepartment of Health Sciences Research, Mayo Clinic, Rochester, MN.
Guoqian JiangDepartment of Health Sciences Research, Mayo Clinic, Rochester, MN.

Funding

Tools for standardizing clinical research metadata using HL7 FHIRU01HG009450 · NHGRI · MAYO CLINIC ROCHESTER · PI JIANG, GUOQIAN · 2016 to 2018
$1.4M
NHGRI NIH HHS U01 HG009450
6 · The paper itself

Abstract

purposeThe Fast Healthcare Interoperability Resources (FHIR) is emerging as a next-generation standards framework developed by HL7 for exchanging electronic health care data. The modeling capability of FHIR in standardizing cancer data has been gaining increasing attention by the cancer research informatics community. However, few studies have been conducted to examine the capability of FHIR in electronic data capture (EDC) applications for effective cancer clinical trials. The objective of this study was to design, develop, and evaluate an FHIR-based method that enables the automation of the case report forms (CRFs) population for cancer clinical trials using real-world electronic health records (EHRs). MATERIALS AND

methodsWe developed an FHIR-based computational pipeline of EDC with a case study for modeling colorectal cancer trials. We first leveraged an existing FHIR-based cancer profile to represent EHR data of patients with colorectal cancer, and then we used the FHIR Questionnaire and QuestionnaireResponse resources to represent the CRFs and their data population. To test the accuracy of and overall quality of the computational pipeline, we used synoptic reports of 287 Mayo Clinic patients with colorectal cancer from 2013 to 2019 with standard measures of precision, recall, and F1 score.

resultsUsing the computational pipeline, a total of 1,037 synoptic reports were successfully converted as the instances of the FHIR-based cancer profile. The average accuracy for converting all data elements (excluding tumor perforation) of the cancer profile was 0.99, using 200 randomly selected records. The average F1 score for populating nine questions of the CRFs in a real-world colorectal cancer trial was 0.95, using 100 randomly selected records.

conclusionWe demonstrated that it is feasible to populate CRFs with EHR data in an automated manner with satisfactory performance. The outcome of the study provides helpful insight into future directions in implementing FHIR-based EDC applications for modern cancer clinical trials.

Indexed as

AlgorithmsClinical Trials as TopicColorectal NeoplasmsElectronic Data ProcessingElectronic Health RecordsHumansMedical InformaticsSoftwareSurveys and Questionnaires

Identifiers

PMID32134686
PMCPMC7113084

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.